BioWorld International Correspondent

PARIS - Transgene SA is set to receive an initial milestone payment of €10 million (US$13.5 million) from F. Hoffmann-La Roche Ltd. before the end of June after obtaining approval from the Federal Drug Administration and the European Medicines Agency (EMEA) for its planned Phase III trial of TG 4001/R3484 (MVA-HPV-IL2), which is being developed for the treatment of high-grade cervical intraepithelial neoplasia (CIN 2/3).

Under the collaboration agreement signed between Roche, of Basel, Switzerland, and Strasbourg, France-based Transgene in April, Roche took over the ongoing development and commercialization of TG 4001, Transgene's leading therapeutic vaccine candidate. The agreement provided for Roche to develop and commercialize products from Transgene's therapeutic vaccine program against human Papilloma virus-mediated diseases, and specifically TG 4001, which targets HPV16, known to be a high-risk factor for the development of precancerous CIN and cervical cancer.

Transgene already received a €13 million (US$17.5 million) up-front payment before that milestone, and could receive up to €195 million more subject to the achievement of certain development and sales-related events in various HPV-related indications. In addition, Transgene will be entitled to double-digit, escalating royalties on sales once a product is marketed.

Roche will fund all future costs associated with the development of TG 4001/R3484, which has completed Phase II trials, and will lead the Phase III trials. The Swiss company will have an exclusive license for TG 4001 and for any other therapeutic vaccine candidates that result from the collaboration in HPV-mediated diseases, including worldwide commercialization rights.

Roche will hold all manufacturing rights but has agreed to award an exclusive commercial contract to Transgene for the supply of TG 4001 for clinical trials and of other HPV products that may be developed in the future.